This application claims priority under 35 U.S.C. § 119 of European Patent Application No. 97202152.1, filed in the European Patent Office on Jul. 17, 1997.
The present invention relates to a stent for use in a body passageway, comprising a flexible self-expanding braided tubular wall being composed of helically wound wires and having proximal and distal ends. The invention also relates to a method for manufacturing such a stent.
A stent of the type as mentioned in the introduction is described for example in U.S. Pat. No. 4,655,771. The tubular wall is composed of several flexible thread elements each of which extends along a helix with the center line of the tubular wall as a common axis. The thread elements are arranged in two groups of opposite directions of winding crossing each other in a way to form a braided configuration. This is to impart to the tubular body the necessary stability for supporting a vessel. The diameter of the tubular wall can be changed by axial movement of the ends relative to each other. The stent is transluminally inserted into position in its radially compressed state and then subjected to expansion staying in place by a permanent pressure against the inner wall of the body passageway. The stability of the tubular body depends in general from the number of the thread elements, their diameter and material and from the braiding angle of the thread elements at their crossings. It is preferred to have the axially directed braiding angle being obtuse, i.e. larger than 90°, in order to obtain a large force in radial directions. But the braiding angle also influences the shortening of the stent, which is the reduction of the scent length upon conversion from its compressed to its expanded state. At a given diameter expansion the stent shortens less at braiding angles smaller than around 120° than at larger angles.
In the following stents with a braiding angle larger than about 120° are referred to as “normal-shortening” whereas stents having a braiding angle of less than about 120° are referred to as “less-shortening.” It is an advantage of less-shortening stents that they can be placed more accurately because the practitioner can better estimate the final positions of the stent ends after expansion. The less-shortening feature comes also to fruition when the stent is implanted in a moving hollow organ in which the stent is repeatedly radially compressed, such as in the esophagus, in the trachea or in a pulsating blood vessel. In those cases the reduced shortening of the stent is less traumatic for the inner wall of the hollow organ since the stent ends perform smaller axial movements than normal-shortening stents do. For the aforesaid reasons less-shortening stents are preferably implanted in ostium regions, for example in the aorta next to the entries into the renal arteries or in side branches. Exact placement capability and less axial movement of the stent ends reduce the risk of unwanted perturbation or obstruction of the blood flow by stent ends projecting into the ostium.
However, stents of the less-shortening type comprise smaller hoop strength compared to normal-shortening prostheses due to their smaller braiding angle. A consequence of the lower radial force is a reduction of the self-fixation characteristics with the risk of a local axial displacement of the stent within the body passageway. Moreover, the stent is not stable enough to resist flattening if it is implanted in arched vessels. This means that a more or less strong deformation of the stent cross-section deviating from its original circular shape can partially close the stent.
In EP-A-O 775 471 an improved stent is disclosed comprising a flexible self-expanding braided tubular wall having a proximal segment of smaller diameter and a distal segment of larger diameter and in-between an intermediate segment forming a truncated cone. A covering layer is arranged within the tubular wall. Although the document does not disclose any specific braiding angles the proximal segment will have a similar braiding angle as the above described less-shortening stent and the distal segment will have a larger braiding angle. The different geometry can be derived from the manufacturing methods as described in the document. The large-diameter segment serves as a migration anchor while the less-shortening segment with smaller diameter makes an easier and safer way through curves or at the end of for example a food pipe. But the less-shortening stent segment still has not sufficient shape stability for use in curved areas of body vessels. The cross-section of this segment may be deformed elliptically if bended in curved body vessels as it will occur generally for less-shortening stents. Moreover, because of the conical shape such a stent can be used only at particular areas, such as in food pipes. In addition, it is to be said that the used manufacturing methods are quite expensive.
All documents cited herein, including the foregoing, are incorporated herein by reference in their entireties for all purposes.